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Compares treatment options for Common Cold
Official title Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
ClinicalTrials.gov ID: NCT06531707
What this study is testing
What is Ibuprofen + Loratadine fixed dose?
Ibuprofen + Loratadine fixed dose is an investigational medicine, given as a twice-daily, being studied as a potential treatment for common cold.
Also referred to as Ibu+Lora.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of Ibuprofen/Loratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Agree to participate in the study and give written informed consent
- At least 6 points on the Jackson scale according to physical examination and questioning (sneezing, runny nose, nasal obstruction, sore throat...
- Symptoms associated with the common cold with maximum of 3 days since presentation
- Women of childbearing potential under a medically acceptable method of contraception
- At the discretion of the Principal Investigator (PI) or treating physician, treatment with the researching product is indicated and may present...
You likely can't join if
- Patients in whom respiratory symptoms are suspected to be of bacterial origin and generate a clinical picture compatible with: Rhinosinusitis...
- Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
- Patients in whom participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
- At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer...
- History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the how well it...
- Patients in whom the study drug is contraindicated for medical reasons
See the full eligibility criteria
- Agree to participate in the study and give written informed consent
- At least 6 points on the Jackson scale according to physical examination and questioning (sneezing, runny nose, nasal obstruction, sore throat, cough, headache, malaise, and chills).
- Symptoms associated with the common cold with maximum of 3 days since presentation
- Women of childbearing potential under a medically acceptable method of contraception
- At the discretion of the Principal Investigator (PI) or treating physician, treatment with the researching product is indicated and may present clinical benefit
- Patients in whom respiratory symptoms are suspected to be of bacterial origin and generate a clinical picture compatible with: Rhinosinusitis (muco-purulent discharge, headache or facial pain, etc.), lower respiratory...
- Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
- Patients in whom participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
- At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with...
- History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the how well it works and safety of the investigational product
- Patients in whom the study drug is contraindicated for medical reasons
- Patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients (Ibuprofen of Loratadine)
- Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
- Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.)
- History of chronic liver failure Child-Pugh A, B, and/or C
- History of acute renal failure (glomerular filtration rate \<30 ml/min/1.72 m2)
- Patients with a history of alcohol or drug abuse in the last year
- Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.